QA Associate

Company : Next-Link

Job Description - QA Associate

As a QA Associate, you drive and support the maintenance and
development of the quality systems of the local quality organization. You
ensure compliance with both local legislation and corporate regulations and the
readiness for inspections and audits. In addition, you drive and support
processes related to marketed products (e.g. batch release, complaints
handling). At the interface between manufacturing and the market, you are the
business partner for various functions.

Major Accountabilities
- Follows GxP and corporate guidelines in day-to-day work.

- Acts as Subject Matter Expert (SME) in the own area of responsibility.

- Takes over process ownership as assigned. The process owner ensures the
proper functioning, monitoring and continuous development of a process within
corporate regulations and local legal requirements. He/she responsible for the
adequate handling of investigations and ensures appropriate training of
relevant roles.

- Responsible for the adequate handling and investigation of deviations
including their CAPAs.

- Is responsible for maintaining and updating the quality management system
within the own area of responsibility.

- Takes over administrative and supportive tasks, where required.

- Supports readiness for all GxP regulatory inspections & audits, as well
as self-inspections according to plan.

- Meets Key Quality Indicators (KQI) in the own area of responsibility.
Assesses, reports and proactively monitors Key Quality Indicators in the own
area of responsibility, maintains good oversight and ensures gaps are
appropriately addressed.

- Drives and executes continuous improvement in his/her area of responsibility.

Requirements

Education & Qualifications

Minimum apprenticeship in Natural Science (e.g. laboratory technician, aide in
Pharmacy, bachelor degree in natural sciences) or comparable
education/scientific background with experience in GxP area.

(3-5) years of professional experience in pharmaceutical
industry, analytics,

quality assurance, production, distribution or pharmacy.

Strong interpersonal, communication, negotiation and problem-solving skills.

Skills in project management, including simplification mindset, strategic
thinking and ability to implement changes.

Language - Fluency in German and English (oral and written is mandatory),
French as advantage

Key Performance Indicators

Performance against Key Quality Indicators in own area of responsibility.

Proactive identification of potential issues and implement remediation plans

Continuous improvement projects executed – driven by compliance and efficiency

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QA Associate

Job Description - QA Associate

Requirements

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